Collaborative Care for Anxiety and Depression in Posttraumatic Epilepsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Emotional Subscale-Change in Quality of Life in Epilepsy-31(QOLIE-31)
研究概览
简要总结
The purpose of this research is to evaluate a 6 month change in quality of life in subjects who receive collaborative care calls compared to those subjects who receive usual neurology care. This is a 2-site trial comparing a 24 week neurology-based collaborative care program to usual neurology care among a total of 60 adults with post-traumatic epilepsy.
详细描述
The study will compare collaborative care versus usual care among N=60 adults with post-traumatic epilepsy and anxiety and/or depression symptoms in Veterans Administration (N=20) and civilian university (N=40) settings at the Salisbury VA and Atrium Health Neurology. This single-blind study will evaluate effectiveness and implementation of a remotely-delivered, 24-week team-delivered collaborative care intervention, with features adapted from VA Primary Care Mental Health Integration and Whole Health, as well as an existing Family Medicine Collaborative Care Program at AHWFB.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures
- •Diagnosis of post-traumatic epilepsy, defined by the following:
- •Epilepsy diagnosis based on neurology clinician impression of diagnosis or electroencephalogram (EEG) findings (EEG findings: presence of interictal epileptiform discharges on EEG or ictal EEG recording of seizure definitively documenting epilepsy diagnosis)
- •History of at least mild traumatic brain injury based on the MIRECC (Mental Illness Research, Education, and Clinical Center) TBI (Traumatic Brain Injury) screening instrument or verified TBI history based on MIRECC research database
- •TBI pre-dated onset of epilepsy (NINDS post-traumatic epilepsy screening form)
- •Anxiety or depression symptoms--Generalized Anxiety Disorder scale (GAD-7) ≥8 or Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) >13
- •Receiving clinical neurological care at one of the study sites
排除标准
- •Active ongoing treatment by a psychiatrist without the potential to benefit from additional collaborative care for anxiety or depression in the judgement of the investigators
- •Active suicidal ideation
- •History of past suicide attempt
- •Unstable drug or alcohol abuse
- •Unstable or progressive comorbid medical condition
- •Current participation in another treatment or intervention study
- •Cognitive limitations precluding completion of anxiety and depression self-report instruments on paper, electronically, or by interview.
研究组 & 干预措施
Collaborative Care
Participants in this arm will receive 24 weeks of neurology based collaborative care.
干预措施: Neurology Based Collaborative Care (Behavioral)
Standard of Care (SOC)
Participants in this arm will receive provider-recommended clinic visits, prescriptions, testing, and referrals.
干预措施: SOC Neurological care (Behavioral)
结局指标
主要结局
Emotional Subscale-Change in Quality of Life in Epilepsy-31(QOLIE-31)
时间窗: Baseline through Month 6
This is a clinically meaningful patient reported outcome measure that was demonstrated to improve in collaborative care efficacy trials in distinct patient groups (including with various different types of medical illness) Score ranges from 0-100 with higher score indicating better quality of life
次要结局
- Change in Beck Depression Inventory-II (BDI-II) score(From baseline through Month 6)
- Subject Adherence to Intervention(Week 12)
- Change in Epilepsy specific QOLIE-31 score(Baseline through Month 6)
- Change in Beck Anxiety Index (BAI) score(From baseline through Month 6)